Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: IDP-122 Lotion; Drug: IDP-122 Vehicle Cream; Drug: Ultravate Cream; Drug: IDP-122 Vehicle Lotion

• Registration Number: NCT02785185
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Detailed Description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

Study Timeline

• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Study Start: 2016-06
• Primary Completion: 2016-12-02
• Study Completion: 2017-01
• Disposition First Submitted: 2018-02-13
• Disposition First Submitted QC: 2018-02-13
• Disposition First Posted: 2018-02-15
• Status Verified: 2020-08
• Results First Submitted: 2020-08-08
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-08-27
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Male or female, of any race, at least 18 years of age (inclusive).
• Freely provides both verbal and written informed consent.
• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
• Subject is willing to comply with study instructions and return to the clinic for required visits.

Key

Exclusion Criteria

• Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
• Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
• Is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-122 Lotion	IDP-122 Lotion	Lotion
IDP-122 Vehicle Cream	IDP-122 Vehicle Cream	Cream
Ultravate Cream	Ultravate Cream	Cream
IDP-122 Vehicle Lotion	IDP-122 Vehicle Lotion	Lotion

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2	2 weeks	Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Week 2. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

Trial Locations

Locations (13)

Valeant Site 10; 🇺🇸 Beverly Hills, California, United States

Valeant Site 09; 🇺🇸 Carlsbad, California, United States

Valeant Site 11; 🇺🇸 North Miami Beach, Florida, United States

Valeant Site 08; 🇺🇸 Albany, Indiana, United States

Valeant Site 03; 🇺🇸 Sanford, Florida, United States

Valeant Site 04; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 06; 🇺🇸 Fridley, Minnesota, United States

Valeant Site 02; 🇺🇸 High Point, North Carolina, United States

Valeant Site 01; 🇺🇸 Houston, Texas, United States

Valeant Site 12; 🇺🇸 Santa Monica, California, United States

Valeant Site 13; 🇺🇸 Los Angeles, California, United States

Valeant Site 05; 🇺🇸 Rogers, Arkansas, United States

Valeant Site 07; 🇺🇸 Coral Gables, Florida, United States